NCT01431235 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Arias AJ, Gelernter J, Chan G, Weiss RD, Brady KT, Farrer L, Kranzler HR
Correlates of co-occurring ADHD in drug-dependent subjects: prevalence and features of substance dependence and psychiatric disorders. Addict Behav. 2008 Sep;33(9):1199-207. doi: 10.1016/j.addbeh.2008.05.003.
Castells X, Ramos-Quiroga JA, Rigau D, Bosch R, Nogueira M, Vidal X, Casas M
Efficacy of methylphenidate for adults with attention-deficit hyperactivity disorder: a meta-regression analysis. CNS Drugs. 2011 Feb;25(2):157-69. doi: 10.2165/11539440-000000000-00000.
Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW
Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.
Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD
Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123.

Investigating the Efficacy of Cognitive Behavioral Therapy in Patients With Substance Use Disorder and Comorbid ADHD. A Randomized Controlled Trial With Cognitive Behavioral Therapy

Details for clinical trial NCT01431235

Clinical trial NCT01431235 - References